Manufacturing Technician – Fractionation

Grifols
Published
January 9, 2022
Location
8368 U.S. Highway 70 West, NC
Category
Job Type
Base Salary
Hourly rate with shift differential & overtime eligibility. Benefits including Health, Dental & Vision insurance, 401k with match & immediate vesting, tuition reimbursement.
Job Hours
3rd shift - 12 hour
Education Requirements
● High school education and completion of the "Bioworks Certification Program" through a community college or ● High school education and 1 year pharmaceutical, chemical, and/or production manufacturing experience in a regulated industry (FDA, USDA, NRC) ● Graduation from an accredited college/university with an Associate’s or Bachelor’s degree in:  Biology, Chemistry, Biochemistry, Engineering, Pharmaceutical Technology, Business, Teaching or a related curriculum (completion of the Bioworks Certificate program through a community college a plus).

Description

For more info & to apply: Fractionation - 316228

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions. 

Fractionation Technician I / II / III - NFF (12-hour, night shift schedule)

 

Summary:

The Fractionation Technician is responsible for performing duties to manufacture products derived from human blood plasma, which require comprehension in the following areas: Science (i.e. biology or chemistry), Engineering, Mechanical aptitude, Computers, Various process equipment (i.e. Centrifuge, Automatic bottle opener, CIP skids) that interface with process controls automation.

 

Primary Responsibilities:

Tech I

● Follow company safety guidelines and programs

● Demonstrate care of facility, equipment, systems, and product

● Demonstrate appropriate personal hygiene and proper gowning

●Follow Standard Operating Procedures (SOP's) and complete Batch Production Records (BPR's)

● Complete record keeping in accordance with current Good Manufacturing Practices

●Operate manufacturing process control system and equipment

● Operate Clean In Place (CIP) equipment

● Perform in process analytical analysis

● Monitor status of manufacturing processes

● Assist in sampling operations

● Assist in the harvest of intermediate products

● Assist in the preparation, set up and transfer of Buffer and Process solutions.

●Transfer intermediate product, raw materials, and waste

● Stage plasma, intermediate paste and raw materials

● Clean and/or Sanitize designated manufacturing areas

● Utilize SAP and / or ACSIS transactions

● Support the supply chain requirements for production

● Assist team members, including supervision, to perform additional tasks

● Work in an ethical and compliant manner to manufacture a drug product that is safe for human use.

 

Tech II

In addition to previously stated responsibilities for Tech I:

● Calibrate analytical equipment for routine use

● Perform DCS setup and monitor setup for manufacturing processes

● Perform sampling operations as required by procedure

● Harvest intermediate products

● Perform proper double checks as required

● Prepare, set up and transfer Buffer and process solutions

● Develop troubleshooting skills for equipment and automation systems

● Perform training for lesser qualified employees

● Assist team members, including supervision, to perform additional tasks

● Perform GMP and safety audits

 

Tech III

In addition to previously stated responsibilities for Tech I & II:

● Enforce safety guidelines and operate established safety programs

● Lead team safety meetings

● Complete and review record keeping in accordance with current Good Manufacturing Practices

● Approve and issue controlled documents

● Calibrate and troubleshoot analytical equipment

● Perform in process analytical analysis

● Perform DCS setup and history retrieval for manufacturing processes

● Assist Coordinator in scheduling processes, personnel and equipment

● Stand in for Coordinator as needed

● Perform operations within Maximo

● Review trends to ensure process parameters are within expected ranges

● Participate in the investigation and resolution of incidents.

● Job performance displays initiative and requires minimal supervision

● Support the supply chain requirements for production with minimal supervision

 

Additional Responsibilities:

Tech I

● Completes assignments in functional areas supporting departmental objectives.

● Communicates effectively and promptly with other operators, technicians and supervisors.

 

Tech II & Tech III

In addition to previously stated responsibilities for Tech I:

● Maintains proper documentation.

 

Knowledge, Skills, & Abilities:

Tech I

● Knowledge of safety guidelines and SOP's established by the company.

● Strong knowledge of current Good Manufacturing Practices (cGMP), and State and Federal Health, Environment and Safety regulations.

● Excellent oral and written communication skills.             

● Comfortable with using different computer systems to perform data entry.                    

● Willingness to work with and learn from other members of the manufacturing team.        

● Desire to enhance one’s skills and knowledge.                                           

 

Tech II & Tech III

In addition to previously stated knowledge, skills, & abilities for Tech I:

● Strong critical thinking and problem solving skills.

● Ability to identify errors and provide corrective actions.

● Develop and maintain necessary skills to stay current with current role and the work environment.

● Ability to train others a plus

 

Requirements:

Tech I

● High school education and completion of the "Bioworks Certification Program" through a community college or

● High school education and 1 year pharmaceutical, chemical, and/or production manufacturing experience in a regulated industry (FDA, USDA, NRC)

● Graduation from an accredited college/university with an Associate’s or Bachelor’s degree in:  Biology, Chemistry, Biochemistry, Engineering, Pharmaceutical Technology, Business, Teaching or a related curriculum (completion of the Bioworks Certificate program through a community college a plus).

 

Additional work experience(s) to be considered to support "Technician" position qualification(s):

● Ability to diagnose and troubleshoot process equipment used in manufacturing environment preferred

● Work experience with distributed control systems and PLC operated equipment preferred

● Experience in protein separation preferred

● Start-up or validation experience preferred

 

Tech II

Requires 12 months as a Technician and on target for a PMP rating of "Achieves Expectations" or 9 months as a Technician and on target for a PMP rating of "Exceeds Expectations" level.

 

Additional work experience(s) to be considered to support "Technician II" level qualifications:

● Ability to diagnose and troubleshoot process equipment used in manufacturing environment required

● Experience in protein separation preferred

● Experience in the pharmaceutical and/or biotechnology industry in any of the following: start-up, validation, asceptic processing, sampling techniques preferred

● Delta V experience preferred

● Completion of the Bioworks Certificate program through a community college preferred

 

Tech III

Requires 12 months as a Technician II and on target for a PMP rating of "Achieves Expectations" or 9 months as a Technician II and on target for a PMP rating of "Exceeds Expectations" level.

 

Additional work experience(s) to be considered to support "Technician III" level qualification(s):

● Ability to independently diagnose and troubleshoot process equipment used in manufacturing environment required

● Distributed Control Systems (DCS) and/or centrifugation experience required

● Experience in protein separation preferred

● SAP and Maximo experience preferred

● Start-up or validation experience preferred

● Completion of the "Bioworks Certification Program" through a community college preferred

 

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements.

 

Occupational Demands:

● Work is performed in a laboratory / manufacturing environment.

● Work schedule requires shift rotation and weekends.

● Exposure to biological fluids with potential exposure to infectious organisms.

● Exposure to electrical and pneumatic powered equipment.

● Exposure to miscellaneous production chemicals, moving machinery and production equipment.

● Potential exposure to high levels of noise on production floor.

● Occasional exposure to -20°C temporary storage freezer in association with storage and retrieval of Plasma and Intermediate paste.

● Personal protective equipment required such as protective eyewear, garments, gloves, safety shoes, head protection, and hearing protection.

● Frequently sits for 4-6 hours per day.

● Frequently walks during working shift.

● Frequent repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. 

● Often performs duties standing.

● Frequently bends and twists at neck and waist.

● Light to moderate lifting and carrying objects with a maximum lift of 50 lbs. 

● Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through  

● Frequently interacts with others, i.e. co-workers, support staff, manager / supervisor.

● Occasional entry into confined spaces, requiring kneeling, climbing and squatting.

● Occasionally works at elevated heights on equipment access platforms and/or ladders.

● Work activities require safe and precise coordinated movements.

 

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